1. Field of the Invention
With reference to the classification of art as established in and by the U. S. Patent Office, the present invention is believed to be found in the medical field and, more particularly, to a securing device for adhesively attaching and retaining a catheter and connected tubing for medication and/or fluids fed from an IV line into a catheter in a patient. This securement device is initially sterilized and with a protective and removable member when removed exposes an adhesively-coated and flexible plastic portion which is utilized for retention of the catheter and connected tubing to the skin of a patient. 2. Description of the Prior Art
The use of an adhesive coating on plastics, particularly thin and flexible plastic film, is very well known. Adhesive tape is and has been used with catheters and the securing of these members to the body parts of the patient being treated. Among U. S. patents of interest is No. 3,046,984 to EBY, as issued July 31, 1962. The retaining member is suggested to be of aluminum foil with an adhesive surface. Retention of a secondary conductor and needle is with a slot and viewing of the flow in the flexible tubing is through a rectangular opening. Also of note is U.S. Pat. No. 3,430,300, as issued to DOAN on Mar. 4, 1969. This patent shows a strip of flexible material with an adhesive surface and a release paper used therewith. The retention of a tube is with a loop formed around the tube and with extending wings of an aperture and wing members inserted through the aperture to secure the tube. Also noted is U.S. Pat. No. 3,918,446 to BUTTARAVOLI, as issued Nov. 11, 1975. This patent depicts a foldover device with appropriate cutouts for guiding the hookup connection and the tubing and to effect a retained and positioned placement. An additional adhesive is provided for securing the device to the skin of the patient. This device is for retaining the IV hookup to and into the vein or artery of a patient. This device does not show or suggest a thin, transparent plastic sheet with peripheral frames to permit ready removal from the added inserting site. BUTTARAVOLI also addressed this securement problem with another U.S. Patent, No. 4,324,237, as issued Apr. 13, 1982. Another U.S. Patent is No. 4,120,304 to MOOR, as issued Oct. 17, 1978, which shows an adhesive member of flexible material and an added clamp member of molded material.
Securing of catheters and connected tubing is also shown in other U.S. Patents, such as No. 3,574,306 to ALDEN, as issued Apr. 13, 1971; No. RE 27,519 to SHEPHERD et al, as issued Oct. 31, 1972; No. 3,973,565 to STEER, as issued Aug. 10, 1976; No. 4,059,105, as issued to CUTRUZZULA et al on Nov. 22, 1977; No. 4,149,534 to TENCZAR, as issued Apr. 17, 1979; No. 4,221,215 to MANDELBAUM, as issued Sept. 9, 1980; No. 4,390,105, as issued to CUMMINGS on June 28, 1983, and No. 4,534,762 to HEYER, as issued Aug. 13, 1985. The above-noted patented examples and other devices known to the Applicant do not teach or contemplate a securement device that has an additional protective member to maintain an initial sterilized condition through storage, shipment and until the attendant prior to immediate use removes this additional protective member to apply the securement device. The readied device is utilized by the attendant to hold a catheter and connected tubular member in position and to the prepped skin of the patient. This (these) release sheet(s) must be removed by the attendant from the securement device prior to use of the securement device.
In brief, and to be more fully described hereinafter, this invention is directed to overcoming these difficulties in providing an initially sterile retainer in which the exposed film is adhesively-coated and provides a securement of the placed catheter and a connected IV tubing and the like. The securement device is shown in two configurations. In a first embodiment, a frame portion is made with three sides and with a fourth side having no frame. In the other embodiment, the securement device has a four-edge frame. In both devices, a flexible film having one face coated with an adhesive is attached to the frame and also to a release sheet. Preferably the release sheet is die-cut as the frame is cut, with the cutout portion of the frame providing the release sheet which is not removed during assembly. This adhesively-coated film is adapted to be attached to the skin of the patient to retain the catheter and a tubular connection. An additional protective member of adhesively-coated film or paper is applied to fully cover the other side of the release sheet until used. One portion of this protective member covers the frame except for an outer portion which is absent adhesive or is covered to make a tab which provides means for insertion of a fingernail or the like. After assembly, the device is sterilized and, after sterilization, this protective member together with the adhesively-coated film provides and maintains internal sterility until time of application.
The skin of the patient is "prepped" for blood vessel puncture, then a catheter is inserted into the vein or artery of said patient. The protective cover of the securement device is removed by gripping the tab and adjacent frame, a one-step procedure. The securement device is ready for placement over the puncture site to secure the catheter and protect the catheter skin entrance site from contamination. The device of this application is shown in two embodiments and, in both, sterility is established and maintained until the protective member is removed just before application. The adhesive has been subjected to sterilization and has been selected from those which are acceptable for use on the human skin. This application is not directed to the composition of adhesive, per se, but to a simple-to-use, economical securement device for retaining a catheter and connected tubing in a substantially near-sterile condition.